NCT02375906

Brief Summary

Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. To improve the current therapeutic options, a better understanding of the pathophysiology is essential. Reliable research in this direction is only possible with large patient study groups. However, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
12 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

8.6 years

First QC Date

February 19, 2015

Last Update Submit

June 1, 2022

Conditions

Hepatitis D

Keywords

HDV, hepatitis delta

Outcome Measures

Primary Outcomes (1)

  • Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide

    10 years

Secondary Outcomes (3)

  • HDV-RNA HBsAg

    10 years

  • HBV-DNA

    10 years

  • Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype

You may qualify if:

  • Positive HBs antigen and antiHDV for longer than 6 months.

You may not qualify if:

  • Absence of any cause of relevant liver disease other than HDV (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Medical University of Vienna; Internal Med.III

Vienna, Austria

Location

Antwerpen University Hospital

Edegem, Belgium

Location

Centro de Pesquisa em Medicina Tropical

Rondônia, Brazil

Location

Medical Center Mrcheveli

Tbilisi, Georgia

Location

Medizinisches Infektiologiezentrum

Berlin, 10439, Germany

Location

Medizinische Klinik I Charite- Campus Benjamin Franklin

Berlin, Germany

Location

Universitätsklinikum Giessen-Marburg

Giessen, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Dep.of Medicine University of Thessalony

Larissa, Greece

Location

Centro di ricerca per lo studio della Epatiti

Bologna, Italy

Location

Gastroenterology Casa Sollievo della Sofferenza Hospital

San Giovanni Rotondo, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino

Torino, Italy

Location

The University of Medicine "Nicolae Testimitanu"

Chisinau, Moldova

Location

Dept.of Medicine Aga Khan University

Karachi, Pakistan

Location

Liverstomach Clinic

Karachi, Pakistan

Location

Clinical Hospital of Infectious Disease "dr. Victor Babes"

Bucharest, Romania

Location

Hospital Vall d´Hebron

Barcelona, Spain

Location

Vietnamese-German Center for Medical Research

Hanoi, Vietnam

Location

Related Publications (1)

  • Wranke A, Pinheiro Borzacov LM, Parana R, Lobato C, Hamid S, Ceausu E, Dalekos GN, Rizzetto M, Turcanu A, Niro GA, Lubna F, Abbas M, Ingiliz P, Buti M, Ferenci P, Vanwolleghem T, Hayden T, Dashdorj N, Motoc A, Cornberg M, Abbas Z, Yurdaydin C, Manns MP, Wedemeyer H, Hardtke S; Hepatitis Delta International Network. Clinical and virological heterogeneity of hepatitis delta in different regions world-wide: The Hepatitis Delta International Network (HDIN). Liver Int. 2018 May;38(5):842-850. doi: 10.1111/liv.13604. Epub 2017 Oct 26.

    PMID: 28963781RESULT

MeSH Terms

Conditions

Hepatitis D

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Michael P Manns, Prof. Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 3, 2015

Study Start

November 1, 2013

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 2, 2022

Record last verified: 2022-06

Locations

GE(1)IT(3)RO(1)BR(1)GR(1)ES(1)BE(1)VN(1)AU(1)PA(2)DE(4)MO(1)